FDA Approves J&J's Rybrevant for NSCLC With Certain Kind of EGFR Mutation

The FDA announced today that it had approved Johnson & Johnson's Rybrevant (amivantamab-vmjw)as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The agency also said it approved the Guardant360 CDx as a companion diagnostic for Rybrevant.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” Julia Beaver, M.D., chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Approximately 2% to 3% of patients with NSCLC have EGFR exon 20 insertion mutations, according to the FDA, which also said that EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.

Johnson & Johnson said in a press release about the approval that currently available targeted treatments, like EGFR tyrosine kinase inhibitors (TKI), aren't effective in treating NSCLC when the tumor cells have EGFR exon 20 insertion mutations and are not FDA-approved for those patients. The company press release also says that NSCLC driven by the EGFR exon 20 insertion mutation have a worse prognosis and shorter survival rates compared with those driven by more common EGFR mutations.